510(k) · Cleared
Recalled · Class II · 2018Polysorb Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jun 25, 1998 as substantially equivalent to K970863 (United States Surgical, A Division of Tyco Healthc, 1997) after a 23-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it. It has been recalled once.
- Decided
- Jun 25, 1998
- Review
- 23 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961997 (1996). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK961997 Ussc Braided Synthetic Absorbable SutureUnited States Surgical, A Division of Tyco Healthc · 1996
- 1 generation backK970863 Modified Ussc* Polysorb SutureUnited States Surgical, A Division of Tyco Healthc · 1997
- This deviceK981935 Polysorb SutureUnited States Surgical, A Division of Tyco Healthc · 1998
- Descendant · cites it directly · 3 of its ownK063536 Polysorb* Synthetic Absorbable Suture with Modified PackagingTyco Healthcare Group · 2007
- Descendant · cites it directly · 2 of its ownK202950 StitchKit COMBOOrigami Surgical · 2021
- Descendant · 2 generations on · 2 of its ownK073614 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK211792 StitchKitOrigami Surgical Inc . · 2021
- Descendant · 3 generations on · 0 of its ownK221527 StitchKitOrigami Surgical Inc . · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K063536Polysorb* Synthetic Absorbable Suture with Modified PackagingTyco Healthcare Group · 2007 · cites it directly3descendants
- K202950StitchKit COMBOOrigami Surgical · 2021 · cites it directly2descendants
- K073614WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · 2 generations on2descendants
- K211792StitchKitOrigami Surgical Inc . · 2021 · 2 generations on1descendant
- K221527StitchKitOrigami Surgical Inc . · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961997 | Ussc Braided Synthetic Absorbable Suture | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| −1 | K970863 | Modified Ussc* Polysorb Suture | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| 0 (this device) | K981935 | Polysorb Suture | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| +1 | K063536 | Polysorb* Synthetic Absorbable Suture with Modified Packaging | Tyco Healthcare Group | 2007 | — |
| +1 | K202950 | StitchKit COMBO | Origami Surgical | 2021 | — |
| +2 | K073614 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +2 | K211792 | StitchKit | Origami Surgical Inc . | 2021 | — |
| +3 | K221527 | StitchKit | Origami Surgical Inc . | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970863 | Modified Ussc* Polysorb SutureSummary page 1…SSIFICATION NAME: Absorbable Surgical Suture COMMON NAME: Synthetic Absorbable Surgical Suture PROPRIETARY NAME: Not yet determined PREDICATE DEVICES: Polysorb* Suture (K970863) DEVICE DESCRIPTION: Modified Polysorb* Suture is composed of a glycolide/lactide copolymer which is a synthetic polyester comp… | 1997 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2018 | Class II | Z-2601-2018 | Nonconforming Material/Component | Potential proplylene glycol contamination |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K063536 (Tyco Healthcare Group, 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981935 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981935: Polysorb Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981935
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026